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STAT+: Pharmalittle: How Pfizer’s Covid vaccine boxes complicated rollout; FDA and J&J near deal to reopen vaccine plant
Good morning! Elizabeth Cooney sitting in for Ed Silverman today as he gets an early…
Category: Pharmalot
STAT+: FDA revives a controversial program the Trump administration ended over ‘inaccuracies’
In an unexpected move, the Food and Drug Administration is reversing a decision by the…
STAT+: Pharmalittle: FDA authorizes another Covid-19 treatment; judge indicates Purdue reorganization plan can be voted on
Top of the morning to you, and a fine one it is. Clear blue skies…
STAT+: Drug makers argue an HHS rule would penalize them for offering co-pay coupons
After months of controversy, the pharmaceutical industry’s biggest trade group has filed a lawsuit accusing…
STAT+: Pharmalittle: Vaccine makers urge Biden to end support of Covid-19 IP waiver; Russia accused of sowing doubt over Pfizer shot
Rise and shine, everyone, the middle of the week is here. You made it this…
STAT+: In a possible sign of transparency, more leading universities are reporting clinical trial results
Over the past two years, many major U.S. universities have done a better job of…
STAT+: What deadline? Most clinical trials are still not reported on time to federal database
Amid ongoing calls for greater clinical trial transparency, a new analysis finds just 40% of…
STAT+: Pharmalittle: Moderna Covid-19 vaccine is effective in adolescents; U.S. lawmakers pitch a bill to create ‘biobonds’
Good morning, everyone, and how are you today? We are doing just fine, thank you,…
STAT+: Lawmakers pitch a bill to create $30 billion in ‘biobonds’ to jumpstart drug development
In a bid to jumpstart drug development, a bipartisan group of lawmakers introduced a bill…
STAT+: European regulatory body plans ‘joint action’ to bolster clinical trial reporting
The Heads of Medicines Agencies, an umbrella group for regulators in 30 European Union countries,…
STAT+: Pharmalittle: BARDA lacks cash to invest in new Covid-19 drug development; AstraZeneca CEO hits back at European Commission
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: Wealthy nations and drug makers offer moves to bridge Covid-19 vaccine divide
The leaders of the world’s wealthiest nations and several drug makers took steps to widen…
STAT+: Pharmalittle: Pfizer and India spar over indemnity for Covid-19 vaccines; J&J to supply Gavi with Covid shots
And so, another working week will soon draw to a close. Not a moment too…
‘There’s so much uncertainty’: As Mallinckrodt sells rare disease drug, parents worry about access
As it looks to emerge from bankruptcy, Mallinckrodt (MNK) has sold an experimental medicine that…
STAT+: Pharmalittle: Iovance CEO resigns amid a regulatory delay; Republican lawmakers urge Biden to reject Covid-19 IP waiver
Hello, everyone, and how are you today? The sun is shining brightly this morning on…
STAT+: What’s in a name? Spark Therapeutics sues Bluebird Bio over the use of the word ‘spark’
A promotional campaign has sparked a legal dispute between Spark Therapeutics and Bluebird Bio (BLUE)…
STAT+: Republican lawmakers tell Biden to reverse ‘disastrous decision’ to support Covid-19 IP waiver
Amid a furious debate over boosting global distribution of Covid-19 vaccines, more than a dozen…
STAT+: Fewer state Medicaid programs are restricting access to hepatitis C medicines, but hurdles remain
Over the past few years, state Medicaid programs have done a better job of disclosing…
STAT+: Emergent was aware of vaccine manufacturing issues even as it collected $27 million a month from U.S.
Under a contract awarded by the Trump administration, Emergent BioSolutions (EBS) was paid $27 million…
STAT+: Pharmalittle: Emergent to be grilled by some House members who received donations; lawmakers ask FTC to probe AbbVie
Rise and shine, everyone, another busy day, and especially so here on the Pharmalot campus,…
STAT+: Your money or else: Some drug makers could be ‘highly’ susceptible to ransomware attacks
The latest high-profile incident of a ransomware attack caused one of the biggest gas and…
STAT+: Pharmalittle: G20 nations water down Covid-19 IP waiver; Biden hopes to grow U.S. share of global vaccine market
Top of the morning to you, and a fine one it is. We enjoy this…
STAT+: Feds tell drug makers to offer discounts to safety-net hospitals or face penalties
After a year of controversy, the Health Resources and Services Administration notified six large drug…
STAT+: Pharmalittle: Sanofi and Glaxo tout positive Covid-19 vaccine results; Pfizer exec warns IP waiver will cause materials shortage
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: Pharmalittle: Congress grills U.S. trade representative over Covid-19 IP waiver; Pfizer shot was target of conspiracy theories
Once again, another working week will soon draw to a close. If you are surprised…
STAT+: Charles River loses a battle over harvesting horseshoe crabs used for testing bacteria in drugs
In a setback to Charles River Laboratories (CRL), a federal judge temporarily blocked its contractors…
STAT+: Pharmalittle: Top Emergent execs will testify before Congress; most Americans don’t trust the FDA or CDC
Top of the morning, and a fine one it is. Clear blue skies and crisp…
STAT+: Brazil’s Supreme Court rules that patent extension rules are unconstitutional
The Brazilian Supreme Court ruled that a provision in the country’s intellectual property law allowing…
STAT+: Most Americans believe Biden is correct to support an IP waiver for Covid-19 vaccines
Nearly two in three Americans believe the Biden administration is correct to support a waiver…
STAT+: A clinical trial coordinator is indicted for falsifying data in a Glaxo asthma drug study
A former study coordinator at a company hired to run a clinical trial of a…
STAT+: Pharmalittle: Key Dems push Pelosi to seek ‘bipartisan’ drug pricing reform; AstraZeneca CEO pay upsets shareholders
Hello, everyone, and how are you this fine, sunny morning? The middle of the week…
STAT+: Sanofi is accused of ‘widespread destruction’ of company e-mails tied to Zantac recalls
As litigation proceeds over the Zantac heartburn pill and a possible carcinogen, a court filing…
STAT+: Pharmalittle: U.K. says IP waiver is insufficient for Covid-19 vaccine access; EU sues AstraZeneca over vaccine supply — again
Rise and shine, another busy day is on the way. We can tell because our…
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STAT+: Dutch advisory group says Zolgensma shouldn’t be covered unless Novartis halves price
In a challenge to Novartis (NVS), a Dutch advisory body has recommended that the government…
STAT+: Pharmalittle: Novavax sees delay in seeking emergency use of its Covid-19 shot; AstraZeneca CEO’s pay causes a stink
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: WHO, international regulatory group urge pharma to publish clinical study reports
In a significant step toward greater transparency, the World Health Organization and the International Coalition…
STAT+: Pharmalittle: Pfizer seeks full FDA approval for its Covid-19 shot; EU is willing to explore Covid-19 IP waiver
And so, another working week will soon draw to a close. Not a moment too…
STAT+: Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales
The Massachusetts attorney general has filed a lawsuit against Publicis Health, one of the world’s…
STAT+: The U.S. opened pandora’s box on IP waivers for Covid-19 vaccines. What happens now?
In a surprising move, the Biden administration has said it will support a controversial proposal…
STAT+: In Belgium, too many clinical trial sponsors waffle about reporting required results
The results of more than one-fifth of clinical trials that were conducted in Belgium have…
STAT+: Pharmalittle: Biden supports WTO proposal on Covid-19 vaccine IP; Biogen Alzheimer’s drug is cost-effective at $2,500
Good morning, everyone, how are you today? We are doing just fine, thank you, as…
STAT+: Incyte pays $12.6 million to resolve claims it paid drug kickbacks through charity
Incyte (INCY) agreed to pay $12.6 million to settle allegations that donations amounted to kickbacks…
STAT+: Biogen’s Alzheimer’s drug may only be cost effective at $2,500 a year
The controversial, but widely anticipated Biogen (BIIB) treatment for Alzheimer’s would only be cost-effective if…
U.S. will back proposal to waive patent rights and boost Covid-19 vaccine production
In a significant move to combat the Covid-19 pandemic, the U.S. government agreed to support…
STAT+: Pharmalittle: Pharma showers a key Democratic senator with cash; Lilly exec accused of altering factory documents
Top of the morning to you. Another busy day is unfolding here on the Pharmalot…
STAT+: Rising wholesale drug prices really do matter to half of all commercially insured Americans
Although the pharmaceutical industry argues that wholesale prices do not accurately reflect prescription drug costs,…
STAT+: Pharmalittle: Pfizer Covid-19 vaccine to generate $26 billion in 2021 sales; EMA reviews Sinovac Covid-19 vaccine
Rise and shine, everyone, another very busy day awaits. Even so, there is nothing like…
STAT+: STAT+ Conversations: An update from STAT’s Pharmalot
Editors note: A livestream of the conversation will be embedded below at 1 p.m. ET….
STAT+: Gilead sues Russia over a compulsory license issued to a company making remdesivir
Amid worldwide clamoring for Covid-19 vaccines and other therapies, Gilead Sciences (GILD) last month filed…
STAT+: European Commission fines a Merck KGaA unit for providing misleading info prior to a merger
The European Commission fined a unit of Merck KGaA $9 million for providing incorrect or…